Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study
Inclusion Criteria:
- A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve
to androgen deprivation therapy, and a candidate for hormonal treatment.
- An estimated survival time of at least twelve months according to the investigator's
assessment.
- A performance status score ≤ 2 according to the World Health Organisation (WHO)
criteria.
Exclusion Criteria:
- Previous surgical castration.
- Previous or has planned curative prostate cancer therapy (radiation/surgery)
- Previous hormone therapy (GnRH analogues, estrogens or anti-androgens)
- Patients with risk of a serious complication in the case of tumour flare (vertebral
metastases threatening spinal cord compression or significant obstructive uropathy)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
PCA3 score expressed as a ratio of PCA3 mRNA (messenger ribonucleic acid) over PSA (prostate specific antigen) mRNA.
Outcome Time Frame:
6 months post-treatment
Safety Issue:
No
Principal Investigator
Patrick Cabri, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Ipsen
Authority:
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study ID:
8-79-52014-168
NCT ID:
NCT01020448
Start Date:
November 2009
Completion Date:
June 2013
Related Keywords:
- Prostate Cancer
- Locally advanced or metastatic Prostate Cancer
- Prostatic Neoplasms
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